On November 26, 2025, BrioHealth BV, in collaboration with Meditrial SrL, announced a clinical trial for the BrioVAD heart pump, targeted at patients suffering from advanced refractory heart failure. This trial is listed under ClinicalTrials.gov with the identifier NCT07252531 and is currently not yet recruiting participants.
What changed?
The BrioVAD trial introduces a novel left ventricular assist device (LVAD) designed to address unmet needs in patients with severe heart failure refractory to standard treatments. The trial aims to assess the safety and effectiveness of LVAD implantation and enhance cardiovascular care for these patients.
Trial details and device purpose
The study, sponsored by BrioHealth BV and supported by Meditrial SrL, focuses on LVAD technology, which assists the heart in pumping blood in individuals with weakened cardiac function. The BrioVAD device is intended for patients with refractory heart failure who have exhausted other therapeutic options.
Clinical trial protocols follow regulatory standards outlined under MDR Annex XIV, ensuring robust evaluation of the device’s safety and performance in a controlled clinical environment.
The trial is expected to shed light on whether this advanced LVAD device can improve survival rates, reduce hospitalizations, and enhance the quality of life for patients with progressive cardiovascular disease.
Who is sponsoring the trial?
BrioHealth BV leads the development of the BrioVAD heart pump, with technical and procedural expertise provided by Meditrial SrL, a renowned medical trial consultancy. Together, these organizations aim to meet regulatory compliance requirements while paving the way for cutting-edge advancements in heart-failure management.
Who is affected?
This trial targets patients diagnosed with refractory heart failure, a condition often characterized by fatigue, shortness of breath, and inability to respond to traditional medical therapies. Healthcare providers, clinical teams, and regulatory professionals focused on CVD outcomes should monitor this trial’s progress closely.
Families and caregivers of individuals with advanced heart failure may also find hope in this research, which has the potential to impact treatment protocols for severe cases.
Impact on regulatory and clinical teams
Clinical and quality teams will benefit from insights into patient response to the BrioVAD device, while regulatory professionals can assess compliance with MDR and other global certification standards. These findings could lead to new benchmarks in cardiovascular device approval timelines and guidelines.
What are the long-term implications?
Successful outcomes from this trial could set a precedent for future LVAD designs, fostering innovation in the cardiovascular device sector and potentially influencing policymaking in Europe and beyond.
FAQs
1. What is the BrioVAD device?
BrioVAD is a left ventricular assist device designed for patients with advanced heart failure and is the focus of the announced clinical trial.
2. When does the trial begin?
The trial is listed as “not yet recruiting,” with official start dates to be announced.
3. Where will the trial take place?
No specific trial sites have been disclosed yet, but it is likely to be conducted in Europe.
4. Who sponsors the study?
BrioHealth BV sponsors the study, partnered with Meditrial SrL for specialist trial expertise.
Conclusion
The BrioVAD trial is set to redefine approaches to managing refractory heart failure through advanced LVAD technology. Regulatory and clinical stakeholders should remain attentive to this trial’s developments, which could yield transformative data for the cardiovascular sector.
Disclaimer
This content is for informational purposes only and does not constitute legal or medical advice. Healthcare and regulatory professionals should consult official guidelines and protocols for compliance and decision-making.
Further reading
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07252531?term=medical+device